[Federal Register Volume 61, Number 119 (Wednesday, June 19, 1996)]
[Proposed Rules]
[Pages 31073-31075]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15478]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 2E4042/P661; FRL-5374-6]
RIN 2070-AC18
Chlorothalonil; Pesticide Tolerance for Use in or on Asparagus
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish a tolerance for combined residues of
the fungicide chlorothalonil and its metabolite in or on the raw
agricultural commodity asparagus. The proposed regulation to establish
a maximum permissible level for residues of the fungicide was requested
in a petition submitted by the Interregional Research Project No. 4
(IR-4).
DATES: Comments, identified by the docket number [PP 2E4042/P661], must
be received on or before July 19, 1996.
ADDRESSES: By mail, submit written comments to: Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW,
Washington, DC 20460. In person, bring comments to: Rm. 1132, CM #2,
1921 Jefferson Davis Highway, Arlington, VA 22202.
Comments and data may also be submitted to OPP by sending
electronic mail (e-mail) to: [email protected]. Electronic
comments must be submitted as an
[[Page 31074]]
ASCII file avoiding the use of special characters and any form of
encryption. Comments and data will also be accepted on disks in
WordPerfect 5.1 file format or ASCII file format. All comments and data
in electronic form must be identified by the docket number [PP 2E4042/
P661]. Electronic comments on this proposed rule may be filed online at
many Federal Depository Libraries. Additional information on electronic
submissions can be found in the ``SUPPLEMENTARY INFORMATION'' section
of this document.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
``Confidential Business Information'' (CBI). CBI should not be
submitted through e-mail. Information marked as CBI will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2. A copy of the comment that does not contain CBI must be submitted
for inclusion in the public record. Information not marked confidential
may be disclosed publicly by EPA without prior notice. All written
comments will be available for public inspection in Rm. 1132 at the
address given above, from 8 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Hoyt L. Jamerson,
Registration Division (7505W), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St. SW., Washington, DC 20460.
Office location and telephone number: Sixth Floor, Crystal Station #1,
2800 Jefferson Davis Highway, Arlington, VA 22202, (703) 308-8783; e-
mail: [email protected].
SUPPLEMENTARY INFORMATION: The Interregional Research Project No. 4
(IR-4), New Jersey Agricultural Experiment Station, P.O. Box 231,
Rutgers University, New Brunswick, NJ 08903, has submitted pesticide
petition (PP) 2E4042 to EPA on behalf of the Agricultural Experiment
Stations of Kentucky, North Carolina, Oklahoma, Virginia, and
Washington.
This petition requests that the Administrator, pursuant to section
408(e) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C.
346a(e), amend 40 CFR 180.275 by establishing a tolerance for combined
residues of the fungicide chlorothalonil [tetrachloroisophthalonitrile]
and its metabolite, 4-hydroxy-2,5,6-trichloroisophthalonitrile, in or
on the raw agricultural commodity asparagus at 0.1 part per million
(ppm).
The scientific data submitted in the petition and other relevant
material have been evaluated. A discussion of the toxicological data
considered in support of the proposed tolerance for asparagus can be
found in a proposed rule (PP 0E3889, 2E4113, and 5E4538/P639) published
in the Federal Register of January 24, 1996 (61 FR 1884). The Federal
Register notice of January 24, 1996, also provides a discussion of the
basis for the EPA's classification of chlorothalonil and
hexachlorobenzene (HCB), a manufacturing impurity found in
chlorothalonil formulations, as probable human carcinogens (Group B2 of
EPA's classification system for carcinogens).
Dietary risk assessments were conducted using Reference Doses
(RfD), the applicable cancer potency factors to assess chronic exposure
and risk from chlorothalonil and HCB residues, and the Margin of
Exposure (MOE) to assess acute toxicity from chlorothalonil residues.
The Reference Dose (RfD) for chlorothalonil is established at 0.018
mg/kg of body weight (bwt)/day, based on a no-observed-effect-level
(NOEL) of 1.8 mg/kg/day from the 2-year feeding study in dogs, which
demonstrated as effects increased urinary bilirubin levels and kidney
vacuolated epithelium, and an uncertainty factor of 100. Available
information on anticipated residues and/or percent of crop treated was
incorporated into the analysis to estimate the Anticipated Residue
Contribution (ARC) from existing uses. The proposed tolerance level of
0.1 ppm and 100 percent crop treated were assumed to estimate dietary
exposure to residues of chlorothalonil from the proposed use on
asparagus. The ARC from existing uses and the proposed uses utilizes
less than 1 percent of the RfD for chlorothalonil for the U.S.
population and all population subgroups. EPA generally has no cause for
concern for exposures below 100 percent of the RfD.
The RfD for HCB is established at 0.0008 mg/kg bwt/day based on a
NOEL of 0.08 mg/kg of bwt/day and an uncertainty factor of 100. The
NOEL was taken from a 130 week feeding study in rats that showed
hepatic centrilobular basophilic chromogenesis. Since there are no
published tolerances for HCB, the ARC was generally calculated by
multiplying the anticipated residues for chlorothalonil by 0.05
percent, an adjustment based on comparisons of residue data for the two
compounds from controlled field trials. The ARC for HCB from existing
uses of chlorothalonil and the proposed use on asparagus utilizes less
than 1 percent of the RfD for the U.S. population and all population
subgroups.
The upper bound carcinogenic risks were calculated using the ARC
estimates for dietary exposure from existing uses and the proposed use
on asparagus, and Q*s (Q stars) of 0.00766 (mg/kg/day)-1 for
chlorothalonil and 1.02 (mg/kg/day)-1 for HCB. The upper bound
carcinogenic risk from existing and all pending uses of chlorothalonil
is estimated at 6.5 x 10-7, with the proposed use for asparagus
contributing 1.05 x 10-8 to the cancer risk assessment. The
upper bound carcinogenic risk for HCB is estimated at 3.2 x 10-7
from existing and all pending uses, with the proposed use for asparagus
contributing 1.2 x 10-7 to the cancer risk assessment. The
proposed use on asparagus would contribute negligible increases in the
total cancer risks from dietary exposure to residues of chlorothalonil
and HCB.
The Margin of Exposure (MOE) is a measure of how closely the high-
end acute dietary exposure comes to the NOEL from the toxicity endpoint
of concern. For chlorothalonil, the MOE was calculated as ratio of the
lowest-observed effect level (LOEL) of 175 mg/kg/day from the
subchronic study in rats. A NOEL was not established since an effect
(renal and gastric lesions) was observed at the single dose tested. An
uncertainty factor of 300 was used to calculate the MOE since there was
no available NOEL from the study. The acute dietary MOE for
chlorothalonil is calculated to be greater than 1,500 for the general
population and all population subgroups. Chlorothalonil poses minimal
acute dietary risk.
The nature of the residue in asparagus is adequately understood.
The parent compound and its metabolite (4-hydroxy- 2,5,6-
trichloroisophthalonitrile) are the regulated residues. An adequate
analytical method, is available for enforcement purposes. The method is
listed in the Pesticide Analytical Manual, Volume II (PAM II).
There is no reasonable expectation that secondary residues will
occur in milk, eggs, or meat, fat, or meat byproducts of livestock or
poultry as a result of this action; there are no livestock feed items
associated with asparagus.
There are presently no actions pending against the continued
registration of this chemical. The pesticide is considered useful for
the purpose for which the tolerance is sought.
Based on the information and data considered, the Agency has
determined that the tolerance established by amending 40 CFR part 180
would
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protect the public health. Therefore, it is proposed that the tolerance
be established as set forth below.
Any person who has registered or submitted an application for
registration of a pesticide, under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) as amended, which contains any of the
ingredients listed herein, may request within 30 days after publication
of this notice in the Federal Register that this rulemaking proposal be
referred to an Advisory Committee in accordance with section 408(e) of
the FFDCA.
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
docket number [PP 2E4042/P661].
A record has been established for this rulemaking under docket
number [PP 2E4042/P661] (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does
not include any information claimed as CBI, is available for inspection
from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The public record is located in Room 1132 of the Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer all comments received electronically into printed,
paper form as they are received and will place the paper copies in the
official rulemaking record which will also include all comments
submitted directly in writing. The official rulemaking record is the
paper record maintained at the Virginia address in ``ADDRESSES'' at the
beginning of this document.
Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency
must determine whether the regulatory action is ``significant'' and
therefore subject to all the requirements of the Executive Order (i.e.,
Regulatory Impact Analysis, review by the Office of Management and
Budget (OMB)). Under section 3(f), the order defines ``significant'' as
those actions likely to lead to a rule (1) having an annual effect on
the economy of $100 million or more, or adversely and materially
affecting a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local or tribal
governments or communities (also known as ``economically
significant''); (2) creating serious inconsistency or otherwise
interfering with an action taken or planned by another agency; (3)
materially altering the budgetary impacts of entitlement, grants, user
fees, or loan programs; or (4) raising novel legal or policy issues
arising out of legal mandates, the President's priorities, or the
principles set forth in t his Executive Order. Pursuant to the terms of
this Executive Order, EPA has determined that this rule is not
``significant'' and is therefore not subject to OMB review.
This action does not impose any enforceable duty, or contain any
``unfunded mandates'' as described in Title II of the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as
specified by Executive Order 12875 (58 FR 58093, October 28, 1993),
entitled Enhancing the Intergovernmental Partnership, or special
consideration as required by Executive Order 12898 (59 FR 7629,
February 16, 1994).
Pursuant to the requirements of the Regulatory Flexibility Act (5
U.S.C. 601-612), the Administrator has determined that regulations
establishing new tolerances or raising tolerance levels or establishing
exemptions from tolerance requirements do not have a significant
economic impact on a substantial number of small entities. A
certification statement explaing the factual basis for this
determination was published in the Federal Register of May 4, 1981 (46
FR 24950).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 4, 1996.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.275, the table in paragraph (a) is amended by adding
alphabetically the raw agricultural commodity asparagus, to read as
follows:
Sec. 180.275 Chlorothalonil; tolerances for residues.
(a) * * *
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Parts per
Commodity million
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* * * * *
Asparagus.................................................. 0.10
* * * * *
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* * * * *
[FR Doc. 96-15478 Filed 6-18-96; 8:45 am]
BILLING CODE 6560-50-F